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Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC
Sponsor: AstraZeneca
Summary
This is a Phase I, multicentre, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, PD, and PK of \[111In\]-FPI-2107 after pre-dose administration of FPI-2053 in Chinese participants with EGFR mutation-positive NSCLC.
Official title: A Phase I Multicentre Open-label Study to Evaluate Safety, Tolerability, and Dosimetry of [111In]-FPI-2107 in Chinese Adult Participants With EGFR Mutation-positive NSCLC
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-02-27
Completion Date
2026-07-21
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
[111In]-FPI-2107
radioimmuno-SPECT agent
FPI-2053
unconjugated/unlabelled bispecific antibody \[cold\]
Locations (3)
Research Site
Beijing, China
Research Site
Shandong, China
Research Site
Wuhan, China